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BOULE MEDICAL AB — FDA Facility Profile

FEI 3004008703

BOULE MEDICAL AB is an FDA-registered facility (FEI 3004008703) located in Spanga Stockholm, SE. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.

Facility Details

Location
Spanga Stockholm (SE)
Registration Expires
N/A
Operations
Source
device

Recent inspections

  • 1308308 (NAI Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053546 (OAI Fri May 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 867558 (NAI Thu Feb 06 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • FR1-0017475-9/11/1 (Fri Nov 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources